Human-interfacing devices (HIDs) are either mass produced over-the-counter products or custom-built products. The former involve little or no consideration of an individual's unique musculoskeletal needs and the latter require a time consuming, complex and costly process. Both approaches assume a static system with little consideration of system dynamics such as changes in the individual and activities. The traditional design process does not effectively address the human body's free or desired motion and can create an unnecessary and unproductive dependency on a given HID. In the specific field of orthotic insoles, for example, incorrectly fitting orthotic insoles can result in a dependency on the orthotic and can promote atrophy of the foot muscles.
In addition to the above, custom HIDs are expensive and complex to produce. For example, many custom orthotic insoles can cost at least several hundred dollars and average two to three months to obtain. Additional time and cost can be incurred through various referrals to podiatrists and fine tuning of the custom orthotic. Typical fine tuning processes are more art than science, and primarily rely on the user's input, the podiatrist's abilities, and the orthotic's propensity for modification. Over-the-counter (OTC) HIDs such as orthotics are typically much less effective than custom HIDs. While OTC orthotics are generally easier to obtain, assessing the need, finding a suitable orthotic, and insuring that they do not cause collateral damage are essentially impossible.
Additionally, HIDs are inherently ambiguous. There is no verifiable way to know if they are working, to what degree, and for how long. Custom orthotics, for example, rely on multiple professionals, their training and experience, and their level of engagement. The bio-mechanic assessment is performed in a clinical environment, prone to interpretation, dependent on the patient performing as if in their natural environment, and does not consider the patient's shoes or changes in physiology, for example. Additionally, the handoff to a third party (e.g., pedorthist) increases the risk of error based on interpretation and missing context. While a well-made orthotic insole can have a long lifespan, for example, it exists in a dynamic system affected by shoe wear, changes in physiology, and activity which receive little, if any, consideration. This typically causes the orthotic not to perform as expected and can potentially contribute to repetitive stress injuries, foot muscle atrophy, and less than optimal performance.
In terms of assessment, a typical assessment for determining the need for and design of an orthotic insole, for example, can include a biomechanical and/or full gait analysis involving one or more methods, such as observation and manual measurements, pressure mapping, videography, photogrammetry, digital scanning, molds, and casts, where pressure mapping can be accomplished through static pressure plates, in-shoe pressure sensors, and/or other wearables. Assessments for other HIDs can involve similar analyses.
In addition to the above, current wearable devices, unless costing thousands of dollars, do not provide clinical grade data and insight from that data, and even the more expensive systems do not track all the needed parameters. They do not design and monitor HIDs, any related HID system or the effect of physical changes in the user. They do not account for user physiology, environment, activity, equipment like shoes, performance, and form, for example. They also do no optimize performance in real time, measure exercise effectiveness, predict repetitive stress injuries or identify functionally fitting equipment, apparel or other related devices. They do not connect health-wellness-fitness (HWF) professionals with their patients/clients or let users share their data with HWF professionals and enable HWF professionals to create custom notifications and enhance their diagnostic and treatment capabilities. They further do not provide telemetry, for example, in conjunction with telemedicine and sports applications.